The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section
356 of this title or as a device granted review priority pursuant to section
360e(d)(5) of this title. Such a designation may be made prior to the submission of—

(1)a request for designation by the sponsor or applicant; or

(2)an application for the investigation of the drug under section
355(i) of this title or section
262(a)(3) of title
42.

Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.

(b) Use of animal trials

A drug for which approval is sought under section
355(b) of this title or section
262 of title
42 on the basis of evidence of effectiveness that is derived from animal studies pursuant to section
123[1] may be designated as a fast track product for purposes of this section.

(c) Priority review of drugs and biological products

A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.

(1)The term “priority countermeasure” has the meaning given such term in section
247d–6(h)(4)[1] of title
42.

(2)The term “priority drugs or biological products” means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in subsec. (d)(2), is section 101(4) ofPub. L. 105–115, which is set out as a note under section
379g of this title.

Codification

Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.